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Trastuzumab Injection

Trastuzumab Injection
Trastuzumab Injection

Trastuzumab Injection Specification

  • Salt Composition
  • Trastuzumab
  • Origin
  • Pharmaceutical
  • Dosage Form
  • Injection
  • Ingredients
  • Trastuzumab, excipients, sterile water for injection (as solvent)
  • Application
  • Oncology, targeted therapy
  • Ph Level
  • Neutral pH (approx. 6.0)
  • Physical Color/Texture
  • White to pale yellow lyophilized powder
  • Fermentation Smell
  • Odorless
  • Storage Instructions
  • Store at 2°C to 8°C, do not freeze
  • Shelf Life
  • 24 months
  • Stability After Reconstitution
  • Use within 24 hours at 2C to 8C
  • Reconstitution Requirement
  • Requires reconstitution before administration
  • Manufactured By
  • Pharmaceutical companies (e.g., Cipla, Reliance, Biocon, Zydus etc.)
  • Formulation Type
  • Lyophilized powder for injection
  • Generic Name
  • Trastuzumab
  • Administration Route
  • Intravenous infusion
  • Preservative Free
  • Yes
  • Regulatory Status
  • Prescription Only Medicine (Rx)
  • Therapeutic Class
  • Antineoplastic agent
  • Contraindications
  • Hypersensitivity to trastuzumab
  • Solvent Provided
  • Sterile water for injection
  • Strength
  • 150 mg/vial or 440 mg/vial (may vary by manufacturer)
  • Molecular Weight
  • ~145 kDa
 
 

About Trastuzumab Injection

Transtuzumab:-

Transtuzumab is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high risk feature.
Trastuzumab is approved to be used alone or with other drugs to treat:

Adenocarcinoma of the stomach or gastroesophageal junction. It is used for HER2 positive (HER2+) disease that has metastasized (spread to other parts of the body) in patients who have not already been treated for metastatic cancer.

Breast cancer that is HER2+. It is used in patients whose disease has not gotten better with other chemotherapy.
Trastuzumab usually is administered intravenously with an initial dose of 4 mg per kilogram of body weight followed by a weekly dose of 2 mg per kilogram of body weight.



Mechanism of Action

Trastuzumab specifically targets the HER2/neu receptor on cancer cells, inhibiting their growth and survival. By binding to these receptors, the drug helps enhance the immune response against tumor cells, contributing to effective targeted therapy in oncology.


Reconstitution and Administration

The lyophilized powder must be reconstituted with the supplied sterile water for injection before use. Following reconstitution, the solution should be gently swirled, not shaken, to ensure dissolution. The medication must be used within 24 hours and is administered through intravenous infusion under healthcare supervision.


Storage and Stability

Trastuzumab Injection should be stored in a refrigerator at 2C to 8C and must not be frozen. Once reconstituted, it should be kept at the same temperature and used within 24 hours to ensure product efficacy and safety.

FAQs of Trastuzumab Injection:


Q: How is Trastuzumab Injection administered to patients?

A: Trastuzumab Injection must be reconstituted with sterile water for injection, followed by intravenous infusion. The infusion is performed in a healthcare setting under the supervision of trained professionals to monitor for any adverse reactions.

Q: What are the main benefits of Trastuzumab Injection in cancer therapy?

A: Trastuzumab provides targeted therapy for HER2-positive cancers by inhibiting cell growth and aiding the immune system in eliminating cancer cells, thus improving treatment outcomes in eligible patients.

Q: When should the reconstituted Trastuzumab solution be used?

A: Once reconstituted, Trastuzumab solution should be used within 24 hours and stored at 2C to 8C to maintain its stability and effectiveness.

Q: What precautions should be taken before administering Trastuzumab Injection?

A: Patients with a known hypersensitivity to trastuzumab must not receive this medication. Administration should always be carried out by healthcare professionals familiar with oncology treatments.

Q: Where should Trastuzumab Injection be stored before use?

A: The vials must be stored in a refrigerator at 2C to 8C. Freezing the product should be avoided to prevent degradation.

Q: What is the process for reconstituting Trastuzumab Injection?

A: Add the provided sterile water for injection to the vial, gently swirl until the powder dissolves completely, avoiding vigorous shaking to maintain the protein structure. Detailed instructions are provided in the product leaflet.

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